00 Front matter and table of contents

Source: MDCG 2020-1 (Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software, March 2020), pages 1-2

Medical Device

Medical Device Coordination Group Document — MDCG 2020-1

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MDCG 2020-1

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

March 2020

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Disclaimer

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

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Title Page

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

Sidebar: Guidance on Clinical Evaluation / Performance Evaluation of Medical Device Software — March 2020

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Table of Contents

1. Purpose — p. 3
2. Scope — p. 3
3. Background — p. 4
   • 3.1. Abbreviations — p. 5
   • 3.2. Formats used within this document — p. 5
   • 3.3. Definitions — p. 5
4. General principles of the MDSW CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) process — p. 9
   • 4.1. Introduction — p. 9
   • 4.2. Determination of the valid clinical association / scientific validity — p. 12
   • 4.3. Technical Performance / Analytical Performance — p. 12
   • 4.4. Clinical Performance — p. 13
     • 4.4.1. Clinical investigations and clinical performance studies — p. 14
     • 4.4.2. Where demonstration of conformity based on clinical data is not deemed appropriate — p. 15
   • 4.5. Final analysis and conclusion of the clinical evaluation (MDR) / performance evaluation (IVDR) — p. 15
   • 4.6. Continuous update of the clinical evaluation (MDR) / performance evaluation (IVDR) — p. 15

• Annex I – Methodological principle for generation of CLINICAL EVIDENCE — p. 17
• Annex II – Examples of CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) strategies — p. 18
  • a) MDSW intended to analyse sleep quality data — p. 18
  • b) MDSW intended for image segmentation — p. 19
  • c) MDSW intended to detect inflammatory bowel diseases (IBD) — p. 20
  • d) Active devices containing MDSW to enable their intended purpose — p. 21
  • e) MDSW which provides an additional user-interface to control an insulin pump — p. 21
  • f) MDSW intended to analyse exhaled CO2 in a life-sustaining device in order to control ventilator settings — p. 21